Healthcare, Digital Marketing and Market Access Strategy - John G. Baresky
3 COVID-19 OPTIONS: IMMUNIZATION, MONOCLONAL ANTIBODY, ANTIVIRAL
by John G. Baresky on 03/17/20
COVID-19 is a worthy opponent for the world's healthcare community: medical professionals and the pharmaceutical, diagnostic, medical device and technology companies that support them
There is an array of organizations deploying substantial clinical, financial and technical resources to develop a solution to the COVID-19 pandemic. Different approaches are being explored as COVID-19 is a new and complex threat. Although it may share similarities to other viral pathogens, its unique characteristics, unknown biological attributes, contagious mobility and varying impact on individuals makes it an unwieldy foe to weaponize bioscience against.
A shared challenge to mitigate or eliminate the threat of COVID-19
Medical professionals, hospitals, health systems, universities, research institutions, government laboratories, biotech and pharmaceutical companies are hotly pursuing a victory against COVID-19. Their playbooks include conventional vaccine development, use of biological therapies including monoclonal antibodies (mAbs) as well as basic and advanced antiviral medications.
Experience and education fueling the effort
Those working on an answer to COVID-19 are applying their experience and knowledge based on past and ongoing threats including Cholera, Dengue, Ebola, H1N1, H5N1, H7N9 Hendra, HIV, Herpes, Marburg, Measles, MERS, Mumps, Nipah, Polio, Rubella, SARS, Typhoid Fever and Zika. The clinical researchers and healthcare data scientists plus medical professionals working with patients and healthcare authorities are sharing their knowledge and learning on-the-go.
$50 Million From The Bill & Melinda Gates Foundation
The lineup of clinical intellect is impressive; the amount of support from governments and even private citizens and charitable groups is admirable. A leading example of enormous generosity: The Bill & Melinda Gates Foundation donated $50 million to 12 pharmaceutical companies to advance COVID-19 research.
Immunizations: the ideal long term solution to COVID-19
A vaccine to prevent COVID-19 or assertively mitigate its ability to cause significant illness is a perfect solution but challenging to come by. It has to be evaluated for efficacy as well as suitability for mass production. A pathogen like COVID-19 will likely require millions of doses of a vaccine to protect those at risk.
Once a vaccine candidate clears those hurdles a manufacturing facility has to be identified that can produce it and additional test batches produced to assure quality standards are met. The creation of a new vaccine can take considerable time, funding and other resources.
Exploring a COVID-19 solution based on mRNA characteristics
CureVac, BionTech, Moderna are three companies with an even more exacting strategy to developing an effective COVID-19 immunization. Their development experience and focus centers on messenger RNA (mRNA) therapeutic dynamcis that align well with the characteristics of COVID-19.
An added plus to this approach, depending on the final formulation if found to be effective, is that the approved candidate could possibly be ramped up for mass production in a short amount of time.
This is a list of leading firms engaged in the development of a COVID-19 immunization:
- BioNTech (NASDAQ: BNTX)
- Clover BioPharmaceuticals (Privately Held)
- CureVac (Privately Held)
- Fosun Pharma (OTCMKTS: SFOSF)
- Gilead (NASDAQ: GILD)
- GlaxoSmithKline (NYSE: GSK)
- Inovio Pharmaceutical (NASDAQ: INV)
- Johnson & Johnson (NYSE: JNJ)
- MIGAL (Research Institute)
- Moderna (NASDAQ: MRNA)
- Pfizer (NYSE: PFZ) – partnering with BioNTech and Fosun
- Regeneron (NASDAQ: RGN)
- Sanofi (NASDAQ: SNY) – partnering with Regeneron
- Takeda (NYSE: TAK)
- VIR Biotechnology (NASDAQ: VIR)
Monoclonal Antibody versus COVID-19
Another approach is the potential of Regeneron’s Kevzara (sarilumab), a monoclonal antibody, against COVID-19. Kevzara is an interleukin-6 (IL-6) receptor antagonist. Kevzara is presently indicated for severe rheumatoid arthritis (RA). IL-6 could be triggering the overactive inflammatory response in the lungs of patients who are critically ill with COVID-19.
Regeneron and Sanofi are partnering to manage clinical trials of Kevzara and closely study the ability of an interleukin-6 (IL-6) receptor antagonist to combat COVID-19’s effects. The use of mAbs is also being explored in the treatment of Ebola virus and Malaria.
Regeneron’s and Sanofi’s exploration is based on the initial signs of success another IL-6 receptor antibody, tocilizumab, had in China against COVID-19. While tocilizumab is still being assessed, China added it to their formal COVID-19 treatment guidelines.
Tocilizumab, developed by Chugai, is
marketed as Actemra by Genentech/Roche in the United States. Actemra has four FDA
approved indications: moderate to severe rheumatoid arthritis, giant cell arthritis, Polyarticular juvenile idiopathic arthritis and systemic juvenile
idiopathic arthritis.
A monoclonal antibody agent effective against COVID-19 would be a welcome answer. They are complex therapies to develop and produce but if highly targeted could bring about the desired results no matter the cost.
Antiviral Medications versus COVID-19
Flu, herpes, HIV and other viral pathogens have large patient populations. They have fostered the development of numerous brand and generic formulations of antiviral medications plus more in pharma pipelines or castoffs from earlier clinical failures against other viruses.
New, old or on the clinical trial scrap heap, there is great potential to align them with COVID-19 to find selections most likely to demonstrate efficacy at a therapeutically acceptable level against it. By inhibiting a viral pathogen's ability to replicate, they slow or stop its progress and enable a patient to better withstand and outdistance its effects.
An antiviral product or a combination of therapies including an antiviral agent, could be a solution to COVID-19. Presently, a combination of a protease inhibitor, Prezista (darunavir) and cobicistat (a pharmacokinetic enhancer), are being evaluated in tandem against COVID-19. Remdesivir, an investigational nucleotide by Gilead, is an example of another antiviral treatment pathway being explored.
Johnson & Johnson has issued a warning regarding use of Prezista for COVID-19. The product was used for treating SARS patients; while SARS and COVID-19 have some similarities, the differences between the two mean Prezista may not be effective against COVID-19.
Data that may indicate its effectiveness against SARS does not convert to efficacy against COVID-19. This is an instance where close clinical study of an agent like Prezista and any adjunctive therapies used to treat COVID-19 is required to confirm level of effectiveness.
Just as with vaccines and mAbs, an antiviral therapy solution must demonstrate efficacy and have the right attributes to be mass-produced then facilities and production processes come next that are rigorously fortified with quality reinforcements.
This is a list of leading companies that develop, manufacture and commercialize antiviral products:
- AbbVie (NYSE: ABV)
- Arbutus Biopharma (NASDAQ: ABUS)
- Aurobindo Pharma (NSE: AUROPHARMA)
- Bristol-Meyers Squibb (NYSE: BMY)
- Gilead (NASDAQ: GILD)
- GlaxoSmithKline (NYSE: GSK)
- Johnson & Johnson (NYSE: JNJ)
- Merck (NYSE: MRK)
- Roche (OTCMKTS: RHHBY)
- Sino Biopharmaceutical (HKG:1177)
Summary
Vaccines, monoclonal antibodies (mAb) and antiviral therapies are just 3 of the options being explored to find an effective agent to deploy against COVID-19. Upfront experience and analytics in qualifying and identifying options is part of the process, critically assessing their activity and outcomes is the next step. It's still too early to tell which of these 3 or other routes to a solution will emerge as the first primary contender.
These approaches, along with many others, are making progress towards an answer to this global threat.The discoveries and advancements made along the way are the building blocks for future healthcare breakthroughs.
FDA APPROVES RECORDATI'S ISTURISA (osilodrostat) TO TREAT CUSHING'S DISEASE
by John G. Baresky on 03/09/20
Isturisa, Developed By Novartis, Scores FDA Approval And Orphan Drug Status
Recordati (BIT: REC) and Novartis have been issued FDA approval for Isturisa. In 2019 Recordati licensed the rights to the product from Novartis and the approval enables Recordati to start recouping its investment. Isturisa further benefits from the FDA approval as it was given Orphan Drug status that establishes 7 years of market exclusivity.
Isturisa is indicated for the treatment of Cushing’s
Disease
Cushing’s Disease is a rare condition in which a patient’s adrenal glands generate an excessive amount of cortisol. Cushing's disease is usually found in adults 30 to 50 years of age and is more prevalent in women. Cortisol affects all tissues and organs in the body; collectively the symptoms and the healthcare problems as a result of excess cortisol are referred to as “Cushing’s Syndrome”.
Osilodrostat is a steroidogenesis inhibitor of 11-Beta-hydroxylase, an enzyme that catalyses the last step of cortisol synthesis in the adrenal cortex. Isturisa is the first therapy that is FDA-approved that treats cortisol overproduction by blocking the 11-beta-hydroxylase enzyme that triggers it.
Isturisa (Type 1 New Molecular Entity) is a tablet which will be available in 1mg, 5mg and 10mg dosages that is taken orally. With its specific indication for Cushing's disease, Isturisa will be a welcome therapeutic option for endocrinologists and other clinicians treating this highly specialized patient care challenge.
Recordati focuses on developing treatments for rare diseases
Founded
in 1990 with origins dating back to 1926, Milan, Italy-based Recordati
has a unique portfolio of products of which only a few besides Isturisa are approved
by the FDA for patient treatment in the United States:
- Chemet (succimer)
capsules
- Cosmegen
(dactinomycin) injection
- Desoxyn CII
(methamphetamine hydrochloride) tablets
- NeoProfen (Ibuprofen
lysine) Injection
- Panhematin
(hemin) injection
- Peganone® (ethotoin)
tablets
- Tranxene
T-TAB (clorazepate dipotassium) tablets
Recordati has additional therapeutic agents approved in Europe, China and other markets.
Recordati's deal with Novartis included the Signifor brand franchise that is also used in the treatment of Cushing's disease
Recordati paid Novartis $390 million for Signifor and Signifor LAR (each indicated for Cushing’s disease and acromegaly in adults who have failed or cannot undergo surgery) plus Isturisa (osilodrostat). Isturisa was not approved by the FDA at the time of the transaction. In addition to the $390 million licensing transaction, Recordati will be providing Novartis with milestone and royalty payments associated with Signifor and Isturisa.
Novartis (NYSE: NVS) generates over $53 billion in annual sales. Presumably their strategy is to concentrate on therapies which produce larger sales numbers (margin and total revenue). The deal with Recordati (a smaller scale organization specializing in more niche market therapies) enables Novartis to generate revenue from products they develop which can be more effectively commercialized by another company.
APPLE AND JOHNSON & JOHNSON LAUNCH DIGITAL HEALTH STUDY
by John G. Baresky on 02/26/20
A large scale digital health initiative
Apple and Johnson & Johnson have launched a new study to detect atrial fibrillation among seniors while promoting wellness and pro-active heart health.
The clinical study
focuses on Atrial Fibrillation
Atrial fibrillation (referred to as "A-fib") is a cardiovascular issue which may increase the risk of strokes and other serious heart-related problems.
Patients over age 65 can pick up a discounted Apple Watch ($49 plus applicable sales tax) at a Best Buy store if they are assigned one for the study or are issued an iPhone app called Heartline which also connects to Medicare’s Blue Button API that provides the patients access to their Medicare billing and claims data.
This unique study is one
of the largest randomized digital health trials in history, at a minimum, the goal
is to recruit 150,000 people.
Collaborating Technology, Clinical and Retail Partners
Its working model is
unique in that it represents a partnership between a technology company (Apple,
NASDAQ: AAPL), a global healthcare conglomerate (Johnnson & Johnson, NYSE:
JNJ) and a retailer (Best Buy, NYSE: BBY) to facilitate the study program.
LUNDBECK'S NEW MIGRAINE DRUG VYEPTI APPROVED BY FDA
by John G. Baresky on 02/23/20
Vyepti: Lundbeck new product launch expected in April 2020 for
Lundbeck
Lundbeck (OTCMKTS: HLUYY) has received
FDA approval for its migraine therapy product Vyepti (eptinezumab-jjmr). Vyepti
is indicated for the preventive treatment of migraine in adults.
Vyepti is an infused pharmaceutical therapy. Lundbeck anticipates the product being
available to prescribers and patients in April 2020.
Vyepti is an early result of Lundbeck’s
purchase of Alder
The product originated from the product pipeline of
Alder Pharmaceuticals. Lundbeck acquired Alder for about $2 billion in
2019.
Vyepti is an intravenous (IV) mAb therapy
The recommended dose of Vyepti is 100 mg every 3 months and it is noted some patients may benefit from a dose of 300 mg. Vyepti is a humanized monoclonal antibody (mAb) that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.
Vyepti will be up against strong competition from Aimovig (Amgen and Novartis), Ajovy (Teva), Emgality (Eli Lilly) and other migraine products.
Lundbeck is a global pharmaceutical
company
Headquartered in Copenhagen, Denmark
with a U.S. base located in Deerfield, Illinois (a Chicago suburb) Lundbeck is
centered on brain and psychiatric pharmaceutical therapies.
Some of Lundbeck's best-known products include:
·
Abilify (aripiprazole)
·
Northera (droxidopa)_
·
Onfi (clobazam)
·
Rexulti (brexpiprazole)
·
Sabril (vigabatrin)
·
Trintellix (vortioxetine)
·
Xenazine (tetrabenazine)
FDA APPROVES 3 PRESCRIPTION DRUGS FOR OVER-THE-COUNTER STATUS
by John G. Baresky on 02/21/20
Three FDA Rx to OTC Switches
Approved
The U.S. Food and Drug Administration (FDA) has approved these 3 products presently available only by prescription to be purchased without one:
- Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1%)
- Approved for itching, redness of eyes triggered by allergies
- Manufactured by Alcon (NYSE: ALC)
- Pataday Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2%)
- Approved for itching, redness of eyes triggered by allergies
- Manufactured by Alcon (NYSE: ALC)
- Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%)
- Approved for arthritis pain
- Manufactured by GlaxoSmithKline (NYSE: GSK)
AMAZON LAUNCHES EMPLOYEE HEALTHCARE PROGRAM "AMAZON CARE"
by John G. Baresky on 02/19/20
Amazon's telehealth / telemedicine employee healthcare program, Amazon Care, is now fully activated
The program is available only to Amazon
corporate headquarters (Seattle, WA) employees and their dependents. The success of its
launch plus care and cost effectiveness may predicate whether or not Amazon roles the wellness and care concept and technical platform out to its other major locations.
Amazon has made significant investments in the program for its success
The clinic component features a combination of telemedicine and in-person services including an in-app video visit with a doctor, nurse practitioner or registered nurse for consultation, diagnosis, treatment, referrals and other patient care support. In-clinic, face-to-face appointments are available and Amazon Care can arrange for a nurse to follow up with a home visit if required.
Amazon Care features a preferred retail pharmacy network
Prescription benefits are part of the program. Amazon Care clinicians will be able to prescribe medications and the patient may have them delivered to their homes or pick them up at a preferred pharmacy. It is not certain if PillPack, Amazon’s mail order pharmacy unit, has a role in the program due to HIPAA and PHI concerns.
Oasis Medical Group is contracted with Amazon
To administer the program, Amazon has an agreement with Oasis Medical, a family practice medical group based in Seattle. Oasis Medical is not owned or operated by Amazon, it is a contracted provider organization. Conceivably, Amazon may add other specialties and providers (allergy, dermatology, OB/GYN, internal medicine,etc.) as they gain more experience with the Amazon Care model, gauge employee satisfaction and weigh economic benefits.
Amazon is a partner in Haven Health, a joint venture founded to explore how to provide employee patient populations with higher
levels of care at less cost
It will be interesting to see if Amazon’s
Haven Health joint venture partners Berkshire Hathaway and JPMorgan Chase
introduce similar programs for their employees and dependents.
Key Performance Indicators for Amazon Care
- Is the program saving Amazon corporate money and are employees more productive from using it?
- Are employees receiving better care and saving money?
- Are the employee dependents using Amazon Care satisfied with the program?
- Can the program be expanded to other Amazon facilities?
- How can the Amazon Care concept and program be commercialized and marketed to other companies?
Learn how Amazon Care was launched and what its goals are
Review this detailed feature-length story to see how Amazon Care went from concept to
reality.
WHO GIVES CORONAVIRUS 2019-nCoV A NAME: COVID-19
by John G. Baresky on 02/11/20
- CO: Coronavirus
- VI: Virus
- D: Disease
- 19: Viral pathogen's year of being found
- Over 1,000 COVID-19 patients have become fatalities
- More than 43,000 COVID-19 patients have been diagnosed with the viral pathogen's illness
- The early discoverer of COVID-19, Dr. Li Wenliang, has died as a result of contracting the disease
SUPER BOWL 54 TV ADS: Can Any Healthcare Company Exceed The Success Of A Family-Owned Business Ad From Super Bowl 51?
by John G. Baresky on 02/01/20The Super Bowl is a global event; marketers and advertisers invest millions in audience research and testing plus media ad spending to air the best television commercials money can buy
- Quality story line with clear and meaningful messaging
- Strong brand and company identification elements
- A unique campaign strategy that aligned network television, website and social media venues to effectively engage audiences worldwide
HORIZON THERAPEUTICS EARNS FDA APPROVAL FOR TEPEZZA - John G. Baresky
by John G. Baresky on 01/26/20
A first for Thyroid
Eye Disease
Horizon's recently
FDA approved Tepezza is
indicated for the treatment of Thyroid Eye Disease (TED). TED is a healthcare
condition associated with the inflammation of the eyes, eye muscles, eyelids,
tear glands and fatty tissues behind the eye.
Tepezza (teprotumumab-trbw) can be
described as a biologic or biotherapy agent as it is a fully human monoclonal
antibody (mAb) and a targeted inhibitor of the insulin-like growth factor 1
receptor (IGF-1R).
Medical issues
associated with TED
TED
is also known as Graves’ Orbitopathy
or Ophthalmopathy and is an autoimmune condition. TED’s symptoms include
outward bulging of the eye which may cause a series of problems such as double
vision, eye pain, light sensitivity or issues with closing the eye. Tepezza may
help some patients prevent more serious challenges with their eyes as a result
of TED including the potential need for surgical procedures. Tepezza is an
injectable product administered via infusion; once every 3 weeks for a total of
8 infusions.
FDA
Director of The Division of Transplant and Ophthalmology Weighs In On Tepezza:
Wiley Chambers, M.D.,
deputy director of the Division of Transplant and Ophthalmology Products in the
FDA’s Center for Drug Evaluation and Research shares these comments about
Tepezza:
“Currently, there are very limited
treatment options for this potentially debilitating disease. This treatment has
the potential to alter the course of the disease, potentially sparing patients
from needing multiple invasive surgeries by providing an alternative, non
surgical treatment option. Additionally, thyroid eye disease is a rare disease
that impacts a small percentage of the population, and for a variety of
reasons, treatments for rare diseases are often unavailable. This approval
represents important progress in the approval of effective treatments for rare
diseases, such as thyroid eye disease.”
FDA requires Horizon
to conduct a post-approval study for Tepezza
As
part of the FDA's approval of Tepezza, Horizon will continue monitoring
Tepezza’s performance in a post marketing study. The study will assess the
product's safety profile in a larger patient population.
About
Horizon Therapeutics
Horizon
Therapeutics (the recently renamed Horizon Pharma) is based in Dublin, Ireland
with a U.S. headquarters located in the Chicago suburb of Lake Forest,
Illinois. Founded in 2005, Horizon's annual revenues are about $1.25 billion.
FRIDAY FEBRUARY 14th IS NATIONAL DONOR DAY ***ORGAN DONOR***
by John G. Baresky on 01/24/20
Organ donation saves lives
National Donor Day is dedicated to organ donors plus the patients and medical professionals needing their help. Advancements in medicine have made incredible progress in organ transplant success but this record of achievement cannot continue without more donors. While more transplant procedures are being conducted each year, many never happen because there were not enough donors.
Organ transplants are more common but still challenging
Since each patient and donor is different, no two transplants are the same.
With each transplant, medical professionals, clinical researchers and other
transplant science stakeholders learn more. For each transplant, medical
professionals conduct an intense and time sensitive assessment of the organ
recipient and the organ donor to determine the best match that will help
increase the chances of success and survival.
Organ transplant patients require considerable care after the procedures are completed
Following the transplant procedure, transplant patients are still at risk for
complications as a result of the transplant including organ rejection. Even with highly effective immunosuppressive
drugs and other therapies plus the care and support of healthcare
professionals, organ rejection can occur years after a transplant is performed.
In some cases the person is added to the transplant waiting list again. Based
on new patients and transplant patients needing a replacement for their
transplanted organ, there is an ongoing demand for more organ donors.
Ten facts about organ donation and organ
transplantation:
Over 120,000 persons in the United States are in need of an organ transplant;
for many of them their very life depends on it
Almost 40,000 organ transplants were conducted in 2019
One organ donor can save the lives of or tremendously improve the quality of
life for 8 people or even more
In the United States more than 700,000 organ transplants have been conducted
since 1988
These are the most common organ transplants:
- Heart
- Intestine
- Kidney
- Liver
- Lung
- Pancreas
- Blood Vessels
- Bones
- Corneas
- Heart Valves
- Ligaments
- Skin Tendons
Survival rates vary depending upon the patient and post-transplant
recovery challenges including organ rejection
A new person is added to the organ transplant list in the United
States every ten minutes
In the United States it is estimated 20
persons die each day
that were waiting for transplants
Organ donation is free and there are no costs to register as an
organ donor
Sign up to be an organ donor or share this information with someone else so they can be an organ donor, too
You can help over 120,000 persons currently waiting for an organ transplant!
Visit this resource to learn how to sign up; if you are
already registered, please share it with those who would like to join yourself
and others as life saving organ donors:
OrganDonor.Gov - U.S. Government Information on Organ
Donation and Transplantation
Spread the word: Friday February 14th is National Donor Day!
AMAZON EXPANDS HEALTHCARE TEAM WITH LATEST HIRE: DR. VIN GUPTA
by John G. Baresky on 01/09/20
Published on 1/22/2020; updated 2/23/2020
Amazon hires Dr. Vin Gupta
Amazon continues to fortify itself with healthcare talent and technology assets. It has ramped up its online pharmacy unit Amazon Pharmacy / PillPack, acquired healthcare software and technology startup Health Navigator plus launched Amazon Comprehend Medical and Amazon Transcribe Medical. Amazon is also involved in a collaboration with the Pittsburgh Health Data Alliance.
Its latest addition is the reported hiring of Dr. Vin Gupta for its Amazon Care unit. Amazon Care (formed in 2019) is dedicated to serving the headquarters staff of Amazon and provides an array of healthcare services to employees and their dependents. Its programs include conventional patient and clinician care visits, telemedicine access plus other medical support and pharmacy services.
Dr. Gupta has a distinguished clinical, commercial and government background
Vin's experience spans these and other organizations in full time and advisory roles:
- Institute of Health Metrics and Evaluation
- Council on Foreign Relations
- U.S. Air Force
- U.S. State Department
- MIT
- NBC News
- Apple
- World Bank Group
- Brigham & Women’s Hospital
He has extensive academic credentials including:
- MPA; Public Administration, Harvard University
- USAF United States Air Command and Staff College
- MSc; International Relations and Affairs, University of Cambridge
- MD; Columbia University College of Physicians and Surgeons
- BA; Chemistry, Princeton University
UNITED STATES FLU SEASON 2019-2020 UPDATE Q & A
by John G. Baresky on 12/28/19
Initially published 1/06/20, updated 2/23/20
The 2019-2020 Flu season is well underway across the United States
The Centers for
Disease Control ( CDC ) plus other government healthcare
agencies and medical professionals are closely monitoring what is shaping up to
be a formidable Flu season.
Who is most at risk for
Flu?
Individuals spanning
infant to elderly are susceptible to the Flu virus. Expectant mothers, seniors and
persons with chronic conditions such as asthma, an airway abnormality or other
respiratory issues, diabetes, hypertension, heart disease, neurological or
neurodevelopmental disease, kidney, liver or blood disease could be more vulnerable
to Flu and severe Flu symptoms.
Who are some of the leading healthcare companies developing and marketing vaccine products to help protect against the Flu?
The largest Flu vaccine manufacturers include:
- AstraZeneca ( NYSE: AZN )
- GlaxoSmithKline ( NYSE: GSK )
- Sanofi ( NASDAQ: SNY )
- Seqirus / CSL ( ASX: CSL )
Most Flu vaccine
formulations are administered via a single injection although an inhaled nasal mist Flu
vaccine is available ( FluMist Quadrivalent manufactured by AstraZeneca ).
Healthcare professionals determine and prescribe which Flu immunization option,
injection or inhaled formulation, is most appropriate for each
patient.
What products are available to treat the Flu for those diagnosed with it?
Depending on the consumer or patient there is an array of over-the-counter medications available which treat Flu symptoms that do not require a prescription.
There are several companies manufacturing Flu antiviral drugs which can be administered to patients with confirmed Flu diagnosis that require a prescription including:
- Rapivab ( peramivir; injection ) - manufactured by CSL
- Relenza ( zanamivir; dry powder for inhalation ) - manufactured by GSK
- Tamiflu ( oseltamivir phosphate; oral ) - manufactured by Roche but also available as as a generic
- Xofluza (baloxavir marboxil; oral) - manufactured by Genentech / Roche ( OTCMKTS: RHHBY )
How is the Flu season unfolding so far?
- The predominant Flu virus strain varies by region
- Age groups are another variable in profiling specific
Flu virus strains
- Nationwide, influenza B/Victoria virus has been the
most frequently reported Flu strain thus far; the second most frequently
occurring is A(H1N1)
- Influenza B/Victoria viruses are most commonly reported
in children age 0-4 years ( 46% of reported viruses) and persons age 5-24 years ( 57% of
reported viruses)
- A(H1N1) pdm09 viruses are most commonly identified in persons age 25-64 years (41% of reported viruses)
- For adults 65 years of age and older almost equal
proportions of influenza A(H1N1) pdm09 ( 38% ) and A(H3N2) viruses ( 37% )
have been reported
- Current hospitalization rate has been 6.6 cases
per 100,000 ( similar to previous Flu season trends at this calendar
interval but on the increase )
- Overall the CDC estimates there have been 4.6 million Flu cases so far this year resulting in about 39,000 hospitalizations and over 2,100
fatalities
What are some ways I can protect myself and others from the Flu?
- It is not too late to get the Flu shot ( or FluMist if appropriate ); there are ample supplies presently available
- Take precautions to avoid contracting and spreading Flu
virus:
- Avoid persons who are sick
- Avoid directly touching eyes, nose, mouth; cover nose
and mouth with a tissue when coughing or sneezing; properly dispose of
the tissue quickly
- Wash hands with soap and water frequently and clean /
disinfect surfaces where hand contact is frequent ( desks, counters,
table tops, cell phones, keyboards, tablets, door handles, remote
controls, appliance handles, etc. )
- If diagnosed with the Flu and prescribed Flu antivirus
medication, patients should be certain to complete the entire course of
therapy and limit close contact with others
ASTELLAS ACQUIRING XYPHOS BIOSCIENCES TO BUILD OUT ONCOLOGY UNIT
by John G. Baresky on 12/27/19
Tokyo-based Astellas buys second California biotech company in less than a month
Astellas Pharma (
OTCMKTS: ALPMY ) is acquiring Xyphos Biosciences in a deal worth
up to $665 million. Astellas is seeking to build out its immuno-oncology business capabilities. This is the
second acquisition Astellas has made in a month. Historically the company has
made few buyouts since it was formed in 2005 from the
merger of Yamanouchi Pharmaceutical and Fujisawa Pharmaceutical.
Xyphos is centered on advanced oncology treatment science
Astellas covets Xyphos’ proprietary molecules which can be
delivered to natural immune cells or to engineered Chimeric Antigen Receptor
(CAR) cells to generate immunotherapies for oncology treatment. The deal
provides Astellas with additional clinical talent plus proprietary processes
and technology focused in novel cancer treatment research and development. Xyphos’ first CAR cell product investigational
agent is in preclinical development and scheduled to be tested in a
first-in-human clinical study in 2021.
Astellas announced a multi-billion dollar deal earlier this month
Earlier in December, 2019 Astellas bought Audentes Therapeutics for $3 billion. Audentes is a biotech firm focused on gene therapy. Xyphos and Audentes are each based in
South San Francisco.
Astellas is a worldwide pharmaceutical leader
Based in Tokyo, Japan with a U.S. headquarters
in Northbrook, Illinois, Astellas is Japan’s second largest pharmaceutical
company ( Takeda is ranked number one). Astellas has over 17,000 employees and
generally speaking is aligned with 5 disease categories:
- Immuno-Oncology
- Immunotherapy
- Neuro-Muscular
- Regenerative
- Gene Therapy
Xyphos is an ideal element
that fits well with Astellas’ corporate strategy. With annual sales of approximately
$12 billion and a market capitalization estimated at $33 billion, Astellas has made assertive moves in 2019 to accelerate its clinical and financial future success from the start in 2020.
John G. Baresky
GENE THERAPY: ROCHE COMMITS OVER $1 BILLION IN SAREPTA THERAPEUTICS DEAL
by John G. Baresky on 12/26/19
Gene
therapy continues to draw multi-billion dollar investments from biotech and
pharmaceutical companies worldwide
Roche (
OTCMKTS: RHHBY ) is committing over $1 billion dollars up front to Sarepta Therapeutics (
NASDAQ: SRPT ) in a licensing deal with
substantially more to follow depending upon the progress of SRP-9001, an investigational gene therapy targeting Duchenne muscular dystrophy.
Roche and
Sarepta develop a product development and licensing deal
Based on its $1.15 billion deal with Sarepta, Roche will have global rights to launch and market SRP-9001 except for the United States:
- Sarepta received $750 million in cash from Roche
- Roche purchased about $400 million of Sarepta stock at $158. 59 per share
For now
Sarepta, based in Cambridge, Massachusetts, has decided to retain the U.S. market sector for its own commercial
ventures. Sarepta will continue to
manage clinical development and production manufacturing of SRP-9001; Roche has
agreed to cover half of the global clinical development costs. If the drug
meets unspecified regulatory and sales milestones, Sarepta could receive up to
$1.7 billion more in funds from Roche, as well as royalties on any net sales,
if SRP-9001 achieves certain regulatory approval requirements as well as sales
revenue targets.
The patient care science of SRP-9001
SRP-9001 has the potential to be a breakthrough therapy in a challenging patient care sector. SRP-9001 is presently in Phase II clinical development. The agent is designed to deliver the micro-dystrophin-encoding gene directly to the muscle tissue for the targeted production of the micro-dystrophin protein.
Sarepta's strategy to fund clinical trials for SRP-9001
With Roche’s investment, Sarepta
can continue to invest in the development of the product and conduct clinical
trials. They are selecting patients for the two-part Phase II
SRP-9001-102; a 40-patient study focused on safety and efficacy of SRP-9001 in
a 48-week randomized, double-blinded, placebo-controlled timeframe plus a
96-week, double-blinded extension period. This clinical study program has an
anticipated wrap up targeting the 4th quarter of 2022.
Based on positive
results, Sarepta and Roche will pursue marketing opportunities worldwide
If the
product is approved, Sarepta will have funds to orchestrate commercialization initiatives to launch the product in the United States. Roche, headquartered in Basel, Switzerland, has the global expertise
and commercial resources that will enable it to move forward in other markets around
the world. Roche, which just completed a $4.3 billion acquisition of gene therapy
company Spark Therapeutics, will be a lucrative partner for Sarepta to market
other gene therapy pipeline products with in the future or perhaps be wholly-acquired
by Roche.
Partnerships and licensing
agreements are popular options for large and mid-sized biotech and
pharmaceutical companies to explore gene therapy commercial opportunities while
avoiding risk
Gene therapy and other
highly-focused clinical research or product development firms do not always
have the financial resources or business structure to orchestrate a complete
commercial lifecycle of their work. Established, publicly-held drug companies frequently
collaborate with gene therapy and other smaller, highly advanced biotherapeutic
concerns. As pipeline candidates move through the clinical trials process, it
is easier to gauge the likelihood of their chances for approval by regulators.
They provide financial support to these activities and when it appears their
success is almost imminent, larger investments and commitments are made to
assure trial completion, approval and subsequent clinical / commercial launch
traction.
The high cost and high risk involved with gene therapy research is a barrier to entry; less firms and highly focused therapies reduce competition in the sector
As an advanced area of life sciences with potential to cure diseases by replacing missing or mutated versions of a gene found in a patient’s cells with healthy copies gene therapy is not a sector many companies can participate in based on time, clinical and financial commitments. Depending on the patient and the genetic-based issue involved, gene therapy in has been proven to significantly reduce or eliminate complex, life threatening conditions. Success in the gene therapy sector also enriches the clinical insights and manufacturing attributes of their organizations which can be applied in other product development ventures outside of the gene therapy realm.
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DANAHER: $21.4 BILLION GE BIOPHARMA DEAL MOVES FORWARD WHILE ENVISTA DIVESTITURE IS COMPLETED
by John G. Baresky on 12/19/19
Published on 12/19/19, updated 2/23/20
Danaher achieves critical European regulatory approval milestone in acquisition of GE biopharma business unit
Danaher ( NYSE: DHW.WD ) is closing out 2019 at full speed with its attention squarely centered on 2020. The European Union has approved their acquisition of GE Biopharma which completes a pivotal stage of their quest to buy one of GE's most prestigious and profitable corporate divisions. To satisfy the European Commission and other government regulatory requirements, Danaher will sell off these operating groups:
- MolDev FortéBio molecular characterization business located in Fremont, California and Shanghai, China
- Pall Biotech chromatography hardware unit operating from Portsmouth, United Kingdom and Westborough, Massachusetts
- Pall Biotech chromatography resins company operating out of Cergy, France
- Pall Biotech Single-Use Tangential Flow Filtration ("SUT TFF") systems located in Portsmouth, United Kingdom and Westborough, Massachusetts plus its stainless-steel Hollow-Fibre TFF (“SS HF TFF”) systems operations in Shanghai, China
- Pall Biotech SoloHill microcarriers and particle validation standards unit based in Farmington Hills, Michigan
With addition of GE biopharma assets, Danaher's business will engage multiple bioprocessing industry sectors
As a combined organization, Danaher and the acquired assets of GE Biopharma Business will be a worldwide leader in products and services aligned with bioprocessing including consumable single-use technology products such as bioreactors, mixers or connectors plus cell culture media and sera, microcarriers, bioprocessing filtration, molecular characterization, microscopy, high-content screening and laboratory filtration. Its enormous portfolio will enable it to embrace the needs of multiple customer stakeholders.
These include academic institutions and commercial research organizations plus an array of companies involved with research, development, manufacturing, and commercialization of products prepared from or used by biological systems such as biopharmaceutical developers and manufacturers, cosmetics, food, fuel, livestock feed and other biochemical product and service providers.
Danaher corporate profile
Headquartered in Washington, D.C., the Danaher organization is generally defined through three business groups:
- Environmental & applied solutions
- Diagnostics
- Life sciences
With the addition of the GE biopharma assets, Danaher’s abilities in each of the 3 will be significantly multiplied and likely reach into new business sectors as well. Excluding the addition of the GE biopharma assets and their revenue potential, Danaher already generates just under $20 billion in annual sales.
Danaher will be disrupting the competitive balance in their business sectors
These top 10 Danaher rivals plus other firms will be sizing up the new competitive threats Danaher is formulating:
- Agilent Technologies ( NYSE: A )
- Bruker Corporation ( NASDAQ: BRKR )
- Harvard Bioscience ( NASDAQ: HBIO )
- Illumina ( NASDAQ: ILMN )
- Lonza Group ( OTCMKTS: LZAGF )
- PerkinElmer ( NYSE: PKI )
- Roche ( OTCMKTS: RHHBY )
- Thermo Fisher Scientific ( NYSE: TMO )
- VWR / Avantor ( privately held )
- Waters Corporation ( NYSE: WAT )
Another strategic corporate development milestone at Danaher is the completion of its dental product assets into a fully independent spinoff known as Envista Holding Corporation which was launched in 2018. Danaher recently accepted an aggregate of 22,921,984 shares of Danaher common stock in exchange for all of its 127,868,000 shares of Envista common stock. Danaher is now completely separated from Envista as it no longer possesses any voting rights or economic interest in the newly formed company.
Danaher spinoff formed a global professional dental product leader
Overlooked in the broader sense of the investor and dental healthcare communities, through spinning off its dental assets to form Envista ( NYSE: NVST ) Danaher launched a professional dental products giant comprised of:
- 3 primary business units: KaVo Kerr, Nobel Biocare, Ormco
- Over 12,000 employees
- More than 30 dental brands and product franchises
- $2.8 billion in annual sales generated from over 150 nations
Danaher's organizational and revenue goal plans for 2020
Moving forward, Danaher will be busy with the arrangements to integrate its new assets and aligning their revenue producing capabilities according to their annual business plan. At the same time, they will be shopping the 4 Pall business units and MolDev FortéBio to interested parties. 2020 will unveil a significantly larger and somewhat redefined Danaher that customers, competitors and investors will be paying much more attention to in the future.
WALGREENS 4 POWER PARTNER PROFILES: KROGER, MCKESSON, MICROSOFT, PRIME THERAPEUTICS
by John G. Baresky on 12/13/19
Commercial synergy, market access and profit in strategic partnerships
Walgreens Boots Alliance (NASDAQ: WBA ) ranks at number 17 on the Fortune 500 list of largest firms. Reportedly they are exploring options to take the company private which may also be a strong signal to other industry leaders that it is open to takeover offers. Regardless of what their ultimate goals are, they remain a global force in retail, pharmacy, wholesaler and other sectors. The company’s CEO, Stefano Pessina, has communicated Walgreens is actively pursuing more partnerships as a business strategy that enable it to generate revenue by asserting its corporate, financial, clinical and operations resources to build market access and revenue while disrupting competitors --without having to deploy excessive funding for complete acquisitions that contribute further to debt loads.
Walgreens Boots Alliance ( WBA ) financial profile based on the formation of its present corporate structure
For many, Walgreens is a widely recognized retail drugstore chain that competes against consumer and pharmacy players such as CVS Health, Target, Walmart, grocery store pharmacies and online juggernaut Amazon's consumer and pharmacy businesses. In 2014, Walgreens completed an acquisition exercise valued at $4.9 billion cash plus 144.3 million common shares valued at $10.7 billion to acquire UK and Swiss-based Alliance Boots ( Walgreens had earlier committed $4 billion cash and 83.4 million common shares to get the deal underway ). Based in Deerfield, Illinois, ( a Chicago suburb ), the new organization, which deems itself as a holding company, immediately transformed into a global, multi-sector competitor.
Primary elements of Walgreens Boots Alliance financial position
- Market capitalization of $50 billion
- Annual sales: $136.86 billion ( 2019 figures which represented a 5.8% increase over 2018 )
- Earnings: $3.982 billion
- Debt: $15 billion
- Ownership stake of 16% held by CEO Stefano Pessina
- Business operations in more than 25 nations
- Over 415,000 employees
- More than 18,500 stores located in 11 countries
- Over 390 distribution centers servicing pharmacies ( including pharmacies not owned by WBA ), physician offices and healthcare provider organizations
- Ownership stake of 26% in AmerisourceBergen, a global leader in healthcare wholesaler operations ranked at number 12 on the Fortune 500 list; annual sales of $153 billion
Based on its success and expertise dating back to 1901, Walgreens
is acknowledged as an industry leader in consumer, pharmacy, wholesale and
other business sectors. While it has various collaborations in place with a
number of entities, it has 4 partnerships with established industry leaders equal to its own scope and scale. They demonstrate how attractive Walgreens is as an ally and business opportunity. Their relationships with Walgreens underscores Walgreens' ability to innovate and operate outside of conventional business model structures to share knowledge and resources which benefits both partners while increasing sales.
U.S. grocery store giant Kroger Co.
Walgreens has been collaborating with grocery store giant Kroger ( NYSE: KR ) in several marketing initiatives and late in 2019 announced the formation of their own GPO, Retail Procurement Alliance. By combining their orders, Kroger and Walgreens seek to lower costs and boost operational efficiencies. The two companies are already selectively marketing each other’s private label brand products in test market stores across the nation.
Cincinnati, Ohio based Kroger operates over 2,800 stores under 17 different names in 35 states with annual sales exceeding $122 billion. By working together, Kroger and Walgreens are developing wider market access for each of their product portfolios while developing synergies to more effectively operate and compete against Amazon, Walmart, Target, CVS Health, Albertsons, Costco plus other grocery and pharmacy rivals.
The global leader in healthcare wholesale operations McKesson Corporation
Late in 2019, Walgreens entered into a collaboration with McKesson, the world’s largest wholesaler. The two companies formed a joint venture to combine each of their drug wholesale units ( Alliance Healthcare Deutschland and GEHE Pharma Handel ) in Germany. McKesson ( NYSE: MCK ) has a 30% stake int the venture and WBA owns the remaining 70%. The organization will optimize efficiencies and strengthen a competitive position in Germany. The joint venture ( yet to be named and still requiring approval by regulators) is exclusively deployed within Germany's borders and does not extend into other nations.
This arrangement is particularly interesting relative to Walgreens 26% ownership in AmerisourceBergen, one of McKesson’s primary competitors. McKesson, headquartered in San Francisco, ranks at number 7 on the Fortune 500 list by producing over $208 billion in yearly sales.
Technology champion and innovator Microsoft Corporation
Early in 2019 Walgreens Boots Alliance entered into a deal with Microsoft to enroll over 380,000 employees in Microsoft 365 cloud apps which encompass mobile, Office 365, security features and other applications. Walgreens will also transition the majority of its IT workload to Azure and Microsoft’s cloud platform. The two organizations are further working on solutions to optimize data workflow throughout WBA including administrative, pharmacy, operations and other areas through artificial intelligence ( AI ) and other technology. Microsoft has deep AI capabilities spanning, voice, advanced machine learning, data science, Internet Of Things ( IoT ) / Interoperability applications and robotics.
This arrangement benefits Walgreens as it gives them access to Microsoft’s technology resources and IT savvy while Microsoft gains a wider presence in the consumer / patient data management, retail, pharmacy, operations and other sectors ripe for advanced technology development. Through the partnership, both are staking a competitive position against a mutual consumer, healthcare and commercial technology rival, Amazon. Ranked at number 24 in the Fortune 500, Seattle based Microsoft churns out more than $110 billion in annual sales.
Blue Cross Blue Shield Pharmacy Benefit Manager Leader Prime Therapeutics
In 2017 Walgreens entered into a partnership arrangement with Prime Therapeutics, one of the largest pharmacy benefit management companies in the United States. The venture, called AllianceRx Walgreens Prime, is a ten year commitment for the 2 partners. Walgreens is the central ( but not exclusive ) retail pharmacy provider for Prime Therapeutics and the two jointly operate a specialty pharmacy plus mail order pharmacy services. AllianceRx Walgreens Prime benefits WBA with enhanced market access to the membership of 14 BCBS plans plus other customer groups.
Prime Therapeutics realizes the benefit of being aligned with a leader in retail, mail and specialty pharmacy services and operations. Prime Therapeutics, based in Eagan, Minnesota, was founded in 1998. It services more than 28 million members and patients. Their cooperative ownership structure is comprised of 14 Blue Cross Blue Shield plans across the United States.
Walgreens building its future through clinical,
operations, and technical transformation plus strategic alliances
Through the company it keeps in strategic partnerships and willingness to reinvent
itself; Walgreens fortifies its ability to profitably grow and
compete. Maximizing its assets and attributes with equally adept and equipped
partners, Walgreens cultivates and improves its organizational effectiveness. Moving forward, Walgreens has numerous options to satisfy the demands of consumers, patients, payers and shareholders while continuing to be a preferred strategic ally for existing and future
partners.
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Twitter: Healthcare & Content Marketing Guy
FIRST TIME: WOMEN COMPRISE MAJORITY OF MEDICAL STUDENTS IN THE U.S.
by John G. Baresky on 12/10/19
Medical school applicants and medical school enrollees transforming based on gender, ethnicity, race
The
Association of American Medical Colleges ( AAMC ) reports that based on its
data, more females than males are enrolled as medical students throughout the
nation. The margin is narrow but reflects an ongoing trend that has been
building over the last several years. This is a breakthrough for women, the medical
community, academia and the nation.
AAMC is a champion for better patient care and healthcare academics
Based in Washington, D.C., AAMC was founded in 1876. AAMC is a non-profit organization. Its members comprise all 154 accredited United States and 17 accredited Canadian medical schools encompassing almost 400 teaching hospitals and health systems, 51 Department of Veterans Affairs ( VA ) medical centers plus over 80 academic medical societies. The AAMC is a healthcare leader dedicated to improving medication education and patient care while driving breakthrough medical research and healthcare innovation.
A
positive and growing trend that cleared a medical school enrollment
milestone in 2017
Presently,
50.5% of all enrolled medical students are women. This number is built from
crossing an earlier landmark threshold from 2017 when for the first time
females outnumbered males as first-year medical students.
Kaiser Family Foundation Data
According to the Kaiser Family Foundation ( KFF ) there were 25,955 medical school graduates in 2018. This number includes allopathic medical school graduates and osteopathic medical school graduates. The top 10 states of combined allopathic and osteopathic graduates were:
- California: 1,477
- Florida: 1,316
- Illinois: 1,315
- Michigan: 1,143
- Missouri: 922
- New York: 2,402
- Ohio: 1,122
- Pennsylvania: 1,910
- Texas: 1,735
- Virginia: 858
Based in San Francisco and founded in 1948, the Kaiser Family Foundation is a commercially and clinically recognized and respected non-profit organization dedicated to the major healthcare issues of the United States and the role of the nation as an influential global healthcare policy leader.
As
an industry, healthcare is becoming more diverse
The
medical school academic sector is changing in many other ways. A greater number
of minorities are applying and the percentage of them being accepted is on the
rise as well.
Data from AAMC reveals a small and steady transformation in healthcare academics and the future healthcare workforce:
- Native American or Alaska Native applicants increased by 4.8% and their acceptance levels increased by 5.5%
- Hispanic or Latino applicants grew by 5.1% and those accepted grew 6.3%
- African American or black applicants rose by 0.6% and those accepted increased by 3.2%
- For African American or black males, their applicant count grew by .5% and those accepted increased by 3.7%
If current trends continue, the physician workforce of the future will be
significantly changed
While women and minorities are presently outnumbered in the physician ranks, the current trends mark an important change from the past norms which is favorable for patients and clinicians moving forward. For persons early in their education and forming ideas about their career aspirations or for those people seeking a change in their existing careers, the prospects of gaining entry into the healthcare industry is greater than ever --including the opportunities for medical doctor roles as long as they can meet the academic rigor ( average GPA of undergraduates admitted to medical school is above 3.7 ) and take on the economic burden involved.
Medical
school expense is a daunting challenge but interest in the healthcare profession
and physician careers is robust
Based on data from the American Medical Student Association ( AMSA ), the annual cost of attending a public medical school ( complete with tuition, fees, and health insurance included ) is approximately $34,592 for in-state students and $58,668 for out-of-state students. This cost rises considerably for those attending private institutions. Private medical school tuition, fees and health insurance average over $50,000 annually for in-state or out-of-state enrollees. These figures are based on statistics from 2016-2017; for public and private universities these costs continue to increase. Founded in 1950, AMSA is a student governed non-profit organization with over 30,000 members that is based in Washington, D.C. which cultivates healthcare academic and student advocacy while providing a framework for educational and clinical communication and networking.
The sustained and growing interest in healthcare as a career and physician-centered roles is encouraging. 20 new medical schools have opened in the last ten years and class sizes have been expanded which has resulted in a 33% growth trend that dates back to 2002.
Americans are living longer; will there be enough physicians to care for us?
Amazingly, the expansion may not be sufficient to meet the healthcare needs of the nation. Thanks to rapidly evolving healthcare knowledge, better techniques and advanced healthcare products as well as a decline in tobacco use, U.S. citizens are living longer. To meet the needs of today and those of future generations, the number of physicians needs to increase as present data indicates a drastic shortfall by up to 122,000 doctors is approaching by the year 2032.
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SANOFI ACQUIRES SYNTHORX FOR $2.5 BILLION TO EXPAND ONCOLOGY PORTFOLIO
by John G. Baresky on 12/10/19
Synthorx: a fourth multi-billion dollar
acquisition for Sanofi in less than 10 years
Sanofi is expanding its oncology therapeutics business through acquiring Synthorx for approximately $2.5 billion. Based in La Jolla, California, Synthorx has a primary focus in immuno-oncology. Synthorx's most current primary development project is THOR-707, a form of interleukin-2 (IL-2) which, if approved and launched, can be deployed to treat multiple solid tumor types as a monotherapy and potentially in combination with checkpoint inhibitors. The agent is intended to increase effector T-cells and natural killer cells that eliminate cancerous cells in patients.
Synthorx has value-added biotech research & development attributes for Sanofi to build on
An added asset for Sanofi in the deal is Synthorx’s Expanded Genetic Alphabet platform. It can be integrated with Sanofi’s existing initiatives in nanobody research and development. This will support Sanofi’s ventures in advanced patient care and healthcare product sectors such as:
- Biologics
- Conjugates
- Protein Fusions
$2.5 billion deal a mega win for
Synthorx investors
Synthorx had gone public in 2018. These three initial backers will realize an enormous windfall from their investments in it:
- Avalon Ventures
- OrbiMed
- RA Capital
Sanofi expanding its ability to compete in advanced pharmaceutical product sectors while stacking on debt
Sanofi, which has been reported to be shopping its consumer healthcare products unit as a spinoff or joint venture that could be worth up to $30 billion, has made three sizable acquisitions since 2011 that, combined with the Synthorx deal, will push up its $28 billion debt load:
- Synthorx: bought for $2.5 billion in 2019
- Bioverativ: acquired for $11.5 billion in 2018 ( a spinoff from Biogen)
- Ablynx purchased for $2.4 billion in 2018
- Genzyme bought for $20 billion in 2011
Based in Paris, France, Sanofi ( NASDAQ: SNY ) is a global contender ranked within the top 10 of pharmaceutical manufacturers. It generates over $42 billion in annual sales and has over 100,000 employees.
Sanofi transforming its corporate organization and clinical focus
The Synthorx deal is part of a newly emerging change in strategy at Sanofi. They are not only seeking to further monetize their consumer healthcare products unit through a spinoff, partnership or outright sale but also to channel more focus into global healthcare opportunities based on clinically complex medicines. Their senior leadership team has communicated they are going to be significantly reducing their clinical and financial investments in the cardiovascular / hypertension and diabetes / endocrinology patient care sectors in favor of more challenging life science commercial opportunities.
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3M EXPLORING SALE OF DRUG DELIVERY SYSTEMS PRODUCT GROUP VALUED AT $1 BILLION
by John G. Baresky on 12/10/19
Could 3M be seeking to boost revenue or pay down long term debt?
3M ( NYSE: MMM ) is reportedly exploring it options to sell or spinoff its drug delivery systems unit. Based in Maplewood, Minnesota ( a suburb of St. Paul ), 3M ( formerly known as the Minnesota Mining and Manufacturing Company ) is a global conglomerate with long established business enterprises in consumer goods, healthcare, industrial products and worker safety.
3M has a robust presence in the healthcare sector
While 3M generates about $33 billion in sales annually, the drug delivery portfolio of products is a smaller part of a substantially large healthcare products unit. It is estimated drug delivery product revenue accounts for less than 2% of 3M’s total annual sales. Medical device manufacturers, brand and generic pharmaceutical manufacturers as well private equity investors can be considered as likely buyers if 3M does move forward with the sale of the business unit.
- Inhalation
- Microneedle
- Nasal
- Packaging
- Transdermal
Possible plans
for proceeds from sale of the drug delivery business unit
If 3M were to spinoff or sell the drug delivery unit, it could be marketed for around $1 billion. 3M may have plans to drop the proceeds of the drug delivery unit into the bottom line of its annual revenue totals or could apply it to pay down some of its long term debt which is approximately $19.4 billion.
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$3 BILLION PLUNGE INTO GENE THERAPY: ASTELLAS ACQUIRES AUDENTES THERAPEUTICS
by John G. Baresky on 12/03/19
Astellas Expands Therapeutic Portfolio With Gene
Therapy Deal
Astellas ( OTCMKTS: ALPMY ) has announced it is
acquiring Audentes Therapeutics ( NASDAQ: BOLD ) for $3 billion and plunge
itself into the gene therapy market. Based in San Francisco, California,
Audentes is a clinical stage research company centering on the development
of AAV-based genetic medicines for people with significant and rare
neuromuscular diseases.
Astellas is a global pharmaceutical leader
Astellas, based in Tokyo, Japan with a U.S.
headquarters in Northbrook, Illinois, is Japan’s second largest pharmaceutical
company ( Takeda is ranked at number 1). The current product portfolio of
Astellas is defined by 4 categories and the addition of Audentes will establish a 5th with
the specialty of genetic therapy:
- Immuno-Oncology
- Immunotherapy
- Neuro-Muscular
- Regenerative
- Gene Therapy
Astellas employs approximately 17,500
worldwide; Audentes has less than 1,000 staff members.
Audentes has developed
a robust pipeline of advanced gene therapies
Audentes' adeno associated virus ( AAV ) gene therapy
technology platform and proprietary production process expertise is applied
in programs spanning 3 modalities:
- Gene Replacement
- Vectorized Exon Skipping
- Vectorized RNA Knockdown
Audentes has committed
significant resources to develop potential approval candidates although risk
remains high in terms of chances of approval by the Food and Drug
Administration ( FDA ) in the United States and the government regulatory
agencies of other nations:
- AT132 X-linked Myotubular Myopathy MTM1 (
Gene Replacement )
- AT845 Pompe GAA ( Gene Replacement )
- AT702 Duchenne Muscular Dystrophy Exons
2, 1-5 ( Vectorized Exon Skipping )
- AT751 Duchenne Muscular Dystrophy Exon 51
( Vectorized Exon Skipping )
- AT753 Duchenne Muscular Dystrophy Exon 53
( Vectorized Exon Skipping )
- AT466 Myotonic Dystrophy DMPK (
Vectorized Exon Skipping / Vectorized RNA Knockdown )
Presently, the leading candidate for approval in the
Auduentes portfolio is AT312 which could happen as early as mid-2020. Its
clinical trial performance has generated good results in the treatment of
X-linked myotubular myopathy (XLMTM) occurring primarily in male infants.
Astellas began
exploring gene therapy marketplace in 2018
Astellas began exploring gene therapy
marketplace in 2018
Astellas has already licensed a gene therapy candidate. In 2018
Astellas entered into a licensing agreement with Juventas Therapeutics for
JVS-100. JVS-100 is a non-viral gene therapy expressed from stromal
cell-derived factor -1 ( SDF-1 ) which is a naturally occurring signaling
protein activating the endogenous tissue repair pathways. Founded in 2007 and
based in Cleveland, Ohio, Juventas is a
private, clinical stage biotechnology company developing novel non-viral gene
therapies which activate natural processes. Their clinical indication
specialties encompass dermal scar prevention, heart failure, peripheral artery
disease and other areas of investigational research and development.
Why is gene therapy
such a hot marketplace for biotech and pharmaceutical companies to invest in?
Gene therapy is an
advanced area of life sciences with potential to cure diseases by replacing
missing or mutated versions of a gene found in a patient’s cells with healthy
copies. Depending on the patient and the genetic challenge involved, gene
therapy in some instances can resolve significant illnesses with one dose.
Because of the advanced clinical technologies involved with developing and
manufacturing gene therapies, they are quite costly and the processes to
develop them are complex and highly coveted by pharmaceutical
manufacturers.
Large and mid-sized
pharmaceutical companies are always seeking to build their clinical and
commercial capabilities. Many product categories are crowded with competition
including:
- Allergy
- Antibiotics
- Cholesterol
- Dermatology
- Diabetes
- Gastraoesophogeal Reflux Disease ( GERD )
- Hypertension
- Oral Contraceptives
- Rheumatology
There are numerous brand
and generic drugs in each of these categories. While the patient population
prescribed these products is in the millions and the medications involved taken
on a daily basis for months if not years, pharmaceutical companies devote large
sums to develop these products and promote them. Then
conversely, they frequently discount the products through market access
strategy measures to contract for favorable positions on managed care
organization ( MCO ), prescription benefit manager ( PBM ) and health system
formularies or group purchasing organization ( GPO ) listings.
While gene therapy and other advanced medications are costly and risky to produce, the investment to promote them following approval is less. The payout is larger as there are less competitors due to their high research & development and production costs plus the narrow indications they are approved for and reduced number of patients they are prescribed to results in significantly higher prices at time of launch.
Astellas is highly selective in its acquisition strategy
It has been almost 10
years since Astellas last made such a sizable acquisition. In 2010, Astellas
acquire OSI Pharmaceuticals for $3.8 billion. With annual sales of
approximately $12 billion and a market capitalization estimated at $33 billion,
Astellas is solidly established in global healthcare markets and has the
clinical and financial resources to cultivate a successful gene therapy
portfolio of products.
Astellas versus the
competition in the gene therapy marketplace
By adding Audentes’ research
& development attributes and manufacturing capabilities plus its
connections with patient groups, academic institutions and the biotech
research community, Astellas assertively positions itself in the expanding gene
therapy marketplace.
Roche
( OTCMKTS: RHHBY ) Novartis ( NYSE: NVS ) and Pfizer ( NYSE: PFE ) are
presently the blue chip pharmaceutical manufacturer leaders in gene therapy.
Roche acquired gene therapy company Spark Therapeutics for $4.8 billion in
2019, Novartis bought up AveXis, another gene therapy leader for $8.7 billion.
Among Pfizer's many investments, they acquired gene therapy producer Bamboo
Therapeutics for $645 million in 2016.
Reportedly
Pfizer and Novartis have been hard at work building
out their gene therapy development and manufacturing capabilities. Pfizer has
allocated about $600 million to gene therapy production and Novartis
slightly less at $500 million.
Potential
gene therapy giants or acquisition targets
Upcoming
gene therapy companies, which could substantially grow on their own if their
pipeline candidates are approved, may also be attractive buyout targets. Some
of the leading gene therapy companies of this caliber include:
- MeiraGTx Holdings PLC (NASDAQ: MGTX )
- Regenxbio Inc. ( NASDAQ: RGNX )
- Sarepta Therapeutics Inc. ( NASDAQ: SRPT )
- Solid Biosciences Inc. ( NASDAQ: SLDB )
- uniQure NV ( NASDAQ: QURE )
- Voyager Therapeutics Inc. ( NASDAQ: VYGR )
While it appears there
are numerous contenders in the gene therapy market, their products are highly niche-focused
so they have less or no competition within each of the therapeutic areas they
are exploring to develop new medicines. The high rate of clinical trial failure
also results in an ongoing reduction of competing agents throughout the product
development cycle.
Drug manufacturers seek to avoid large
financial outlays and risk involved with gene therapy and other biotherapy
product development
Many large and mid-sized companies owned by the
investment community prefer to have smaller, highly-focused companies develop
products like gene therapies first. As they progress through the approval
process, the pharma companies either license or buy outright the product or the
firm when approval by regulators seems imminent. In advance, these companies
may partially fund the research necessary to develop the products. Audentes
provides Astellas with a solid candidate to enter the gene therapy market with
and hopefully generate other products in the future.
Astellas and Audentes deal approval and
product approval timelines
Even before the Astellas and Audentes deal is approved by regulators, the approval of AT132 X-linked Myotubular Myopathy MTM1 ( Gene Replacement ) will be highly anticipated by investors, company staff members and the medical community. Depending when the deal is approved and AT132 is approved, a combined torrent of activity will follow. Astellas and Audentes could be working to integrate their organizational structures and launching a strategic product venture at the same time. As 2020 rapidly approaches, each company has much to accomplish and look forward to.